Fromilid pills coated 250mg №14

Fromilid /Fromilid

Composition and release form

Fromilid - coated tablets:

1 tab. contains Clarithromycin 250 and 500 mg, excipients: corn starch; MCC (Avicel PH 101); MCC (Avicel PH 102); silica colloidal anhydrous; pregelatinized starch; polacriline potassium; talc; Magnesium stearate;

in a blister of 7 pcs.; in a pack of cardboard 2 blisters.

Frommilid - granules for the preparation of suspensions for oral administration:

1 fl. (25 g granules) contains clarithromycin 1.5 g, excipients: carbomer 934P; Povidone; hypromellose phthalate (HP 55); talc; Castor oil; xanthan gum; banana flavor; anhydrous citric acid; potassium sorbate; silica colloidal anhydrous; titanium dioxide; sucrose;

in dark glass bottles of 100 ml (with a dosing syringe).

pharmachologic effect

Fromilid has antibacterial, bacteriostatic, bactericidal action.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to Frommilide:

upper respiratory tract infections (acute and chronic tonsillopharyngitis, acute and chronic recurrent sinusitis, acute otitis media);

infections of the lower respiratory tract (acute bacterial bronchitis, exacerbation of chronic bronchitis, community-acquired bacterial pneumonia, including pneumonia caused by atypical pathogens);

skin and soft tissue infections;

infections caused by mycobacteria (Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium marinum, Mycobacterium leprae);

prevention of the spread of infections caused by the Mycobacterium avium complex (MAC) in HIV-infected patients with a CD4 (T-helper lymphocyte) lymphocyte count of not more than 100 in 1 mm3;

Helicobacter pylori eradication in patients with duodenal ulcer or stomach ulcer (always in combination with other drugs).

Contraindications

Hypersensitivity to clarithromycin or other macrolide antibacterial drugs or from other components of Fromilid;

severe liver failure;

hepatitis (in history);

porphyria;

I trimester of pregnancy;

lactation period;

simultaneous therapy with terfenadine, cisapride, pimozide, or astemizole;

children up to 6 months (for the dosage form - granules for the preparation of a suspension for oral administration) - there is not enough experience regarding the effectiveness and safety of use;

children under 12 years old and / or body weight less than 33 kg (for the dosage form - film-coated tablets);

congenital fructose intolerance, glucose / galactose malabsorption syndrome or deficiency of the enzyme sucrase-isomaltase (only for the dosage form, granules for the preparation of oral suspension).

With care: II-III trimesters of pregnancy, moderate and severe renal failure, liver failure.

Side effects

On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain, stomatitis, glossitis, short-term discoloration of teeth and tongue, pancreatitis, pseudomembranous enterocolitis, cholestatic jaundice, hepatitis. Impaired liver function can be severe, but usually reversible. Very rarely, there were cases of liver failure and death, mainly due to severe concomitant diseases and / or concomitant drug therapy.

From the central and peripheral nervous system: headache, vertigo, paresthesia, drowsiness, hallucinations, convulsions, psychosis, dizziness, confusion, fear, insomnia, nightmares, depersonalization, disorientation.

On the part of the blood-forming organs and the lymphatic system: leukopenia, thrombocytopenia.

On the part of the senses: change in taste (dysgeusia), smell; ringing in the ears, short-term hearing loss, passing after discontinuation of the drug.

Since the cardiovascular system: prolongation of the QT interval on the ECG, ventricular tachycardia of the "pirouette" type ("torsades de pointes").

On the part of the respiratory system: shortness of breath.

From the musculoskeletal system: arthralgia, myalgia.

On the part of the urogenital system: interstitial nephritis, renal failure.

Allergic reactions: skin rash, urticaria, pruritus, swelling of the face, anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, angioedema.

Dosage and administration

Fromilid is taken orally, swallowing whole, without breaking, washed down with a small amount of liquid.

Adults and children over the age of 12 years and / or body weight ≥33 kg. Fromilid is usually prescribed 250 mg every 12 hours. For the treatment of acute sinusitis, severe infections and when the infection is caused by Haemophilus influenzae, 500 mg of clarithromycin every 12 hours is prescribed. The course of treatment is 7-14 days.

Children under 12 years of age and / or body weight less than 33 kg are usually prescribed Fromilid suspension in a dose of 15 mg / kg / day divided into 2 doses. It is recommended to give some liquid after taking the suspension. The maximum daily dose is 2 g.

Storage conditions and shelf life

Store in a cool and dark place, protected from light and moisture, at a temperature not higher than 20 ° C. Shelf life - 5 years.